How Can We Better Harmonize Approval and Coverage Decisions Between the FDA and the Centers for Medical Services?

There are ways to certainly improved coordination while respecting the different authorities and mandates for these agencies. One example that's already in practice is a am called parallel review, which c m s and f d implinded together first in 20 11 as a pilot and later in 20 16 more formally. The manufacturers could choose to submit through this programme and be able to engage both regulators at the same time. That way, instead of waiting for an f d decision before them going to c m s for a c m s decision, they could try to start those proceses lar.